PreDiabetesPhase 4NCT03938389
The Renin-Angiotensin-Aldosterone System in Adiposity, Blood Pressure and Glucose in African Americans
A Phase 4 study testing Sacubitril-Valsartan Tab 97-103 MG and Valsartan 160mg in people with PreDiabetes and Impaired Glucose Tolerance, run by Ohio State University at 1 site in United States.
Trial summary
The primary objective is to examine the impact of the Renin-Angiotensin-Aldosterone System (RAAS) blockade with medications (valsartan) or RAAS and neprilysin inhibition (valsartan/sacubitril) vs. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- PreDiabetes, Impaired Glucose Tolerance, Obesity
- What is being tested?
- Sacubitril-Valsartan Tab 97-103 MG and Valsartan 160mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Feb 2020to Jun 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- African Americans aged 18-65 years old with a history of impaired fasting glucose, impaired glucose tolerance, hemoglobin A1c 5.7-6.4% or other risk factors for diabetes including metabolic syndrome, family history of type 2 diabetes in the parents or siblings or history of gestational diabetes will be invited to attend a formal screening visit. Participants with impaired glucose tolerance defined as 2-hour plasma glucose 140-199 mg/dl after a fasting 75-g oral glucose tolerance test and who meet other enrollment criteria will be enrolled.
Who cannot join
- Type 2 Diabetes (American Diabetes Association Criteria)
- Hypertension with systolic blood pressure (SBP) > 150 mmHg or diastolic blood pressure (DBP) > 100 mmHg or taking anti-hypertensive medications
- SBP < 100 mmHg or DBP < 60 mmHg
- Pharmacologic treatment with statins, β-Blockers, angiotensin converting enzyme inhibitors, angiotensin II receptor blockers, renin inhibitors, and/or mineralocorticoid antagonists
- Steroid use
- Hyperkalemia (Potassium > 5.0 milliequivalent/L)
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- Abnormal renal function tests: Glomerular Filtration Rate calculated using the Chronic Kidney Disease Epidemiology Equation < 60 ml/min/1.73 m²
- Treatment with oral hypoglycemic medications,
- Use of antipsychotic medications or severe psychiatric disorders (severe mental illness)
- Severe Psychiatric Disorders:
- Schizophrenia
- Paranoid and other psychotic disorders
- Bipolar disorders (hypomanic, manic, depressive, and mixed)
- Major depressive disorders (single episode or recurrent)
- Schizoaffective disorders (bipolar or depressive)
- Pervasive developmental disorders
- Obsessive-compulsive disorders
- Depression in childhood and adolescence
- Panic disorder
- Post-traumatic stress disorders (acute, chronic, or with delayed onset)
- Bulimia Nervosa
- Anorexia Nervosa
- History of, or planned, bariatric surgery,
- Weight loss > 5% over the previous 6 months,
- Pregnancy, planning to conceive a child in the next 9 months, or progesterone based contraception and unable to switch to non-progesterone based contraception,
- Previous or current diagnosis of cardiac structural and functional abnormalities, history or current diagnosis of heart failure (New York Heart Association classes II-IV), history of myocardial infarction, coronary bypass surgery, or percutaneous coronary intervention during the 6 months prior to screening,
- History of angioedema, or known hypersensitivity to study drugs.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
About this study
Official title: The Role of the Renin-Angiotensin-Aldosterone System in Adiposity, Blood Pressure and Glucose Metabolism Among African Americans: Pilot Study
The primary objective is to examine the impact of the Renin-Angiotensin-Aldosterone System (RAAS) blockade with medications (valsartan) or RAAS and neprilysin inhibition (valsartan/sacubitril) vs. placebo on changes in blood sugar and insulin secretion from the pancreas over 26 weeks assessed with glucose clamp studies among African Americans (AAs) with impaired glucose tolerance.
The investigators hypothesize that combined RAAS/neprilysin inhibition will lead to greater improvement in insulin release from the pancreas and improved blood sugar compared to RAAS inhibition alone among AAs with impaired glucose tolerance.
- Conditions
- PreDiabetes, Impaired Glucose Tolerance, Obesity, Blood Pressure
- Being tested
- Sacubitril-Valsartan Tab 97-103 MG, Valsartan 160mg, Placebo Oral Tablet
- Keywords
- African American, Black, Prediabetes, Impaired Glucose Tolerance
- Medical subject headings
- Prediabetic State, Glucose Intolerance, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacubitril-Valsartan Tab 97-103 MGDrug
Also called Entresto
Participants will take Sacubitril-Valsartan for 26 weeks
Valsartan 160mgDrug
Also called Diovan
Participant will take Valsartan for 26 weeks
Placebo Oral TabletDrug
Participant with take placebo for 26 weeks or if blood pressure elevated will receive standard of care blood pressure medication, amlodipine.
| Study group | Role | What they receive |
|---|---|---|
| Valsartan | Active comparator | Valsartan 160 mg twice daily for 26 weeks Receives: Drug: Valsartan 160mg |
| Sacubitril/Valsartan | Experimental | Sacubitril/Valsartan (97/103 mg) twice daily for 26 weeks Receives: Drug: Sacubitril-Valsartan Tab 97-103 MG |
| Placebo | Placebo comparator | placebo (+/- amlodipine 2.5-5 mg twice daily if high blood pressure) Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline to 26 weeks in β-cell function (first-phase insulin secretion)
β-cell function will be assessed by first-phase insulin secretion, calculated as the mean insulin concentration (uIU/mL) over 10 minutes during the hyperglycemic clamp.
Measured: 26 weeks
Secondary outcomes (1)
Change in Central Aortic Pressure (mmHg) from Baseline to 26 weeks
Central Aortic Pressure, measured via a non-invasive method using the SphygmoCor XCEL device, in mmHg.
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2019
- Study start25 Feb 2020
- Primary completion8 Feb 2024
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized prospective controlled clinical trial with three parallel arms, no crossover.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joshua Joseph, MD, Ohio State University
- Investigators
- Joshua J Joseph, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03938389
- Sponsor's protocol ID
- 2018H0061
- Other IDs
- K23DK117041
- Status last verified
- Aug 2025
- First submitted
- 1 May 2019
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of the Renin-Angiotensin-Aldosterone System in Adiposity, Blood Pressure and Glucose Metabolism Among African Americans: Pilot Study
- ClinicalTrials.gov ID
- NCT03938389
- Acronym / sponsor ID
- 2018H0061
- Conditions
- PreDiabetes, Impaired Glucose Tolerance, Obesity, Blood Pressure
- Keywords
- African American, Black, Prediabetes, Impaired Glucose Tolerance
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 25 Feb 2020 (actual)
- Primary completion
- 8 Feb 2024 (actual)
- Study completion
- Jun 2026 (estimated)
- First posted
- 6 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective is to examine the impact of the Renin-Angiotensin-Aldosterone System (RAAS) blockade with medications (valsartan) or RAAS and neprilysin inhibition (valsartan/sacubitril) vs. placebo on changes in blood sugar and insulin secretion from the pancreas over 26 weeks assessed with glucose clamp studies among African Americans (AAs) with impaired glucose tolerance.
The investigators hypothesize that combined RAAS/neprilysin inhibition will lead to greater improvement in insulin release from the pancreas and improved blood sugar compared to RAAS inhibition alone among AAs with impaired glucose tolerance.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized prospective controlled clinical trial with three parallel arms, no crossover.
| Arm | Type | Receives |
|---|---|---|
| Valsartan | Active comparator | Drug: Valsartan 160mgValsartan 160 mg twice daily for 26 weeks |
| Sacubitril/Valsartan | Experimental | Drug: Sacubitril-Valsartan Tab 97-103 MGSacubitril/Valsartan (97/103 mg) twice daily for 26 weeks |
| Placebo | Placebo comparator | Drug: Placebo Oral Tabletplacebo (+/- amlodipine 2.5-5 mg twice daily if high blood pressure) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- African Americans aged 18-65 years old with a history of impaired fasting glucose, impaired glucose tolerance, hemoglobin A1c 5.7-6.4% or other risk factors for diabetes including metabolic syndrome, family history of type 2 diabetes in the parents or siblings or history of gestational diabetes will be invited to attend a formal screening visit. Participants with impaired glucose tolerance defined as 2-hour plasma glucose 140-199 mg/dl after a fasting 75-g oral glucose tolerance test and who meet other enrollment criteria will be enrolled.
Key exclusion criteria (27 listed)
- Type 2 Diabetes (American Diabetes Association Criteria)
- Hypertension with systolic blood pressure (SBP) > 150 mmHg or diastolic blood pressure (DBP) > 100 mmHg or taking anti-hypertensive medications
- SBP < 100 mmHg or DBP < 60 mmHg
- Pharmacologic treatment with statins, β-Blockers, angiotensin converting enzyme inhibitors, angiotensin II receptor blockers, renin inhibitors, and/or mineralocorticoid antagonists
- Steroid use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sacubitril-Valsartan Tab 97-103 MGAlso: EntrestoParticipants will take Sacubitril-Valsartan for 26 weeks | Drug | Sacubitril/Valsartan |
| Valsartan 160mgAlso: DiovanParticipant will take Valsartan for 26 weeks | Drug | Valsartan |
| Placebo Oral TabletParticipant with take placebo for 26 weeks or if blood pressure elevated will receive standard of care blood pressure medication, amlodipine. | Drug | Placebo |
Primary outcome
Change from Baseline to 26 weeks in β-cell function (first-phase insulin secretion)
Time frame: 26 weeks
β-cell function will be assessed by first-phase insulin secretion, calculated as the mean insulin concentration (uIU/mL) over 10 minutes during the hyperglycemic clamp.
1 secondary outcome
Change in Central Aortic Pressure (mmHg) from Baseline to 26 weeks
Time frame: 26 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joshua J Joseph, MD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sacubitril-Valsartan Tab 97-103 MG and Valsartan 160mg in people with PreDiabetes and Impaired Glucose Tolerance, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline to 26 weeks in β-cell function (first-phase insulin secretion) (time frame: 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.